SYNDESMOSIS TIGHTROPE PRO IMPLANT, TI

Additional Manufacturer Narrative

INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.

Description of Event or Problem

ON 27-MAY-2026, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT TWO AR-9925T SYNDESMOSIS TIGHTROPE PRO IMPLANT DEVICES HAD AN ISSUE AFTER PULLING THE RED TAB AND PULLING BACK ON THE BLACK BUTTON TO DEPLOY AND FLIP THE BUTTON, THE BUTTON STAYED ON THE INSERTER AND DID NOT FLIP. TO GET THE BUTTON TO DEPLOY, THE SURGEON HAD TO PUSH THE BLACK BUTTON BACK TO ITS STARTING POSITION ON THE INSERTER TO FINALLY GET THE BUTTON TO RELEASE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2026, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 02-JUN-2026: THE PROCEDURE PERFORMED WAS AN ANKLE FRACTURE REPAIR. BOTH AR-9925T SYNDESMOSIS TIGHTROPE PRO IMPLANT DEVICES ASSOCIATED WITH THE ISSUE WERE UTILIZED DURING THE CASE; ONE DEVICE WAS IMPLANTED, AND THE OTHER WAS OPENED BUT ULTIMATELY NOT USED AND WAS DISCARDED. TO COMPLETE THE PROCEDURE, A SECOND TIGHTROPE DEVICE WAS USED AS A REPLACEMENT. THE INTRAOPERATIVE DELAY WAS MINIMAL, ESTIMATED AT APPROXIMATELY 5-10 MINUTES, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. NO COMPONENTS OF THE INSTRUMENT OR IMPLANT WERE REPORTED TO HAVE BROKEN.